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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL160761-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to find out more about the effectiveness of Tadalafil in improving hemodynamic capabilities, endothelial function, and end-organ function in patients who have previously undergone a Fontan Palliation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tadalafil Group | Experimental | Study participants will receive 10 mg of Tadalafil daily for 1 week, then 20 mg daily for 1 week, and finally 40 mg daily for 50 weeks for a total therapy time of 52 weeks. Tadalafil will be taken orally in capsule form once daily. |
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| Placebo Group | Placebo Comparator | Study participants will receive a placebo capsule that looks identical to the Tadalafil capsule. The placebo will be taken orally once daily for 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil | Drug | 10 mg once daily orally week 1, 20 mg once daily orally during week 2, and 40 mg once daily orally during weeks 3 through 52 |
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| Measure | Description | Time Frame |
|---|---|---|
| Microvascular endothelial function | Measured by the reactive hyperemic index using peripheral artery tonometry (EndoPAT) | 52 weeks |
| Pulmonary vascular reserve | The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO) | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Liver stiffness | Liver magnetic resonance elastography (MRE) will be used to assess liver stiffness expressed in Pascals (Pa) | 52 weeks |
| Renal function | Measured by the glomerular filtration rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ACHD Research Team | Contact | 507-293-2565 | RSTACHDRESPRG@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexander C Egbe, MBBS, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Looks exactly like the study drug, but it contains no active ingredient |
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| 52 weeks |
| Exercise capacity | Assessed using peak VO2 (oxygen consumption) obtained from an upright treadmill or supine bike cardiopulmonary exercise test with echocardiogram | 52 weeks |
| Patient reported quality of life | Measured by the Minnesota Living with Heart Failure Questionnaire that asks subjects to rate how much their heart failure (heart condition) has affected their life during the past month (4 weeks) on a scale of 0=no and 5=very much. | 52 weeks |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |